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在美国,嗜酸性肉芽肿性多血管炎的真实世界美泊利单抗治疗可减轻疾病负担。

Real-world mepolizumab treatment in eosinophilic granulomatosis with polyangiitis reduces disease burden in the United States.

作者信息

Mathur Sameer K, Silver Jared, MacKnight Sean D, Urosevic Ana, Martinez Cristina, Zhang Kaixin, Laliberté François, Deb Arijita

机构信息

Division of Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin, Madison, Wisconsin.

US Medical Affairs - Respiratory, GSK, Durham, North Carolina.

出版信息

Ann Allergy Asthma Immunol. 2025 Mar;134(3):341-350.e2. doi: 10.1016/j.anai.2024.11.004. Epub 2024 Nov 15.

DOI:10.1016/j.anai.2024.11.004
PMID:39549986
Abstract

BACKGROUND

Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare, chronic inflammatory disease characterized by asthma and small/medium vessel vasculitis. Mepolizumab is approved for use in EGPA disease management alongside oral corticosteroids (OCS), but evidence of its real-world impact is limited.

OBJECTIVE

To compare real-world treatment patterns and health outcomes, particularly OCS use, EGPA-related hospitalizations/relapses, and asthma exacerbations pre- and post-mepolizumab initiation in US patients with EGPA.

METHODS

Patients with EGPA receiving more than or equal to 2 mepolizumab doses were identified using administrative claims data from Komodo Health's Comprehensive Dataset (between December 2016-March 2020). Outcomes assessed pre- and post-mepolizumab initiation included corticosteroid/other medication use, EGPA-related hospitalizations/relapses, and asthma exacerbations.

RESULTS

Overall, 114 patients were identified; of these, 60 (53%) received mepolizumab 300 mg at index. Average daily OCS dose per dispensing was significantly lower post- vs pre-mepolizumab initiation (21.2 vs 26.8 mg/d, 21% relative reduction, P < .001); mean number of OCS bursts also decreased (0.9 vs 1.8, 50% relative reduction, P < .001). Patients experienced significantly lower rates of EGPA-related hospitalization (0.86 vs 1.55 per-person year [PPY], 49% relative reduction, P = .004) and EGPA relapse (3.18 vs 3.94 PPY, 19% relative reduction, P = .004) post- vs pre-initiation. Most patients (91%) had an asthma diagnosis at baseline; among these patients, asthma exacerbation rates were significantly lower post- vs pre-initiation (1.05 vs 1.84 PPY, 42% relative reduction, P = .004).

CONCLUSION

Mepolizumab was associated with significant steroid-sparing benefits and significantly reduced rates of EGPA-related hospitalizations, EGPA relapses, and asthma exacerbations in this real-world study of US patients with EGPA, confirming the benefits of mepolizumab treatment seen in clinical trials.

摘要

背景

嗜酸性肉芽肿性多血管炎(EGPA)是一种罕见的慢性炎症性疾病,其特征为哮喘和中小血管血管炎。美泊利单抗已获批与口服糖皮质激素(OCS)联合用于EGPA的疾病管理,但关于其实际影响的证据有限。

目的

比较美国EGPA患者在开始使用美泊利单抗之前和之后的实际治疗模式和健康结局,特别是OCS的使用、与EGPA相关的住院/复发以及哮喘加重情况。

方法

使用来自科莫多健康综合数据集(2016年12月至2020年3月)的管理索赔数据,识别接受了大于或等于2剂美泊利单抗的EGPA患者。在开始使用美泊利单抗之前和之后评估的结局包括糖皮质激素/其他药物的使用、与EGPA相关的住院/复发以及哮喘加重情况。

结果

总体而言,共识别出114例患者;其中,60例(53%)在索引时接受了300mg美泊利单抗。与开始使用美泊利单抗之前相比,每次配药时的平均每日OCS剂量在之后显著降低(21.2 vs 26.8mg/d,相对降低21%,P <.001);OCS冲击的平均次数也减少了(0.9 vs 1.8,相对降低50%,P <.001)。与开始使用美泊利单抗之前相比,患者与EGPA相关的住院率(0.86 vs 1.55人年[PPY],相对降低49%,P =.004)和EGPA复发率(3.18 vs 3.94 PPY,相对降低19%,P =.004)在之后显著降低。大多数患者(91%)在基线时有哮喘诊断;在这些患者中,与开始使用美泊利单抗之前相比,哮喘加重率在之后显著降低(1.05 vs 1.84 PPY,相对降低42%,P =.004)。

结论

在这项针对美国EGPA患者的真实世界研究中,美泊利单抗具有显著的激素节省效益,并显著降低了与EGPA相关的住院率、EGPA复发率和哮喘加重率,证实了在临床试验中观察到的美泊利单抗治疗的益处。

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